← Product Code [FTL](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FTL) · K002071

# SOFTFORM SOFT TISSUE AUGMENTATION TUBE WITH INSERTION TOOL MODIFICATIONS FOR STRANDS AND SUTURE HOLES (K002071)

_Tissue Technologies, Inc. · FTL · Jul 24, 2000 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FTL/K002071

## Device Facts

- **Applicant:** Tissue Technologies, Inc.
- **Product Code:** [FTL](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FTL.md)
- **Decision Date:** Jul 24, 2000
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.3300
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery

## Regulatory Identification

Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.

---

**Source:** [https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FTL/K002071](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FTL/K002071)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com